Moving Ahead: Final Report

Open Call for Consultation

Members

Preamble

In large part, research organizations in Canada operate to high ethical standards and involve the dedication of many people. The current system of human research participant protection faces increasing pressures related to issues such as governance, transparency and public accountability. To address these pressures, the research community needs a shared vision that will define and build a process that further develops a system to protect research participants while facilitating research that is important to society. Given the national and international implications, it is time for all players to work together toward common solutions based on an open and transparent process. The Experts Committee will be formed by the Sponsors’ Table for Human Research Participant Protection in Canada to develop and assess an accreditation and alternative systems for human research participant protection in Canada. Involvement of a wide range of expertise is expected to provide a thorough consideration of the issues and enhance transparency of the process.

Mandate

To provide expert advice on the development of a system for human research participant protection in Canada, considering accreditation and alternative models, and taking into account different levels and types of risk in research. This process will include an assessment of existing means of ensuring human research participant protection for various types of research and of the gaps that such a system would address.

Membership

• Members of the Committee, including the Chair, will be appointed by the Sponsors’ Table. The Committee will be of the order of 12 members. The Chair of the Experts Committee will be involved in selecting Committee members.

• Members are chosen for their expertise and are not representative of any organization. The following areas of expertise will be considered for representation on the Committee:
  • Research Ethics
    
  • Health Law
    
  • Research Ethics Board Administration
    
  • Research Ethics Board Membership (both biomedical and social/human sciences)
    
  • Administration of Health Care
    
  • Research Administration
    
  • Accreditation Systems and Standards Processes
    
  • Social Science and Humanities Research and Methodologies
    
  • Clinical Trials Expert
    
  • Clinical Researcher
    
  • Natural Sciences Research
    
  • Aboriginal Research
    
  • Research Participant Perspective

Criteria for Membership include:

• The appropriate experience, knowledge, expertise, and judgment for the Committee’s purpose
  
• A commitment to the mandate, activities and time requirements of the Committee
  
• A willingness to serve in a voluntary capacity
  
• Ability to work in a committee or advisory panel setting
  
• Impartiality
  
• No financial or other significant conflict of interest.

On striking the Committee, consideration will be given to the overall balance of perspectives, as well as regional, linguistic and gender representation.

Authority/Reporting Structure

• The Committee will report to the Sponsors’ table and has full authority with regard to the substantive elements of its work. In advance, the Committee will share its publications with the Sponsors’ Table to allow for appropriate lead times in anticipation of any potential responses. The Committee will conduct its work based on consensus. If consensus cannot be reached on a given matter, dissenting views should be brought to the attention of the Sponsors’ Table with a recommendation on how the matter could be resolved. Members of the Sponsors’ Table will, both individually and collectively and along with others involved in human research participant protection, utilize the Experts Committee’s findings to consider next steps, in accordance with each respective organization’s mandate and responsibilities.

Communication

• The Committee will openly communicate its activities via a publicly accessible web site. The Committee will share information with the Sponsors’ Table on a regular basis as part of a mutual understanding that both parties communicate with one another freely and to enable either party to prepare any necessary communication lines as are necessary.

Secretariat

• The Committee will be supported by a secretariat (shared with the Sponsors’ Table) that will plan meetings, prepare relevant documentation for meetings and meeting summaries, and generally provide support required by the Committee.

Scope of Work

• The Committee will develop and submit a work plan for approval by the Sponsors’ Table, which will outline the Committee’s proposed activities and expected expenses. Components of the work plan may include, exploring the details of an accreditation or alternative system, a consultation strategy, the development a business plan for an accreditation or alternative system, and the establishment of working groups. The Sponsors’ Table would approve the work plan.
  
• Its work should be transparent and inclusive, foster critical dialogue, make use of existing expertise, and take into consideration the work of the National Council on Ethics in Human Research in this area, along with other investigations into the governance of research involving humans.
  
• At the end of its mandate, the Committee will report on the development and critical assessment of an accreditation or alternative system for human research participant protection, which addresses at least the following questions:

The Concept:

• What is accreditation? What are some alternative systems? What are the goals of an accreditation or alternative system? What problems can these systems reasonably resolve in relation to other approaches and what problems could they create, i.e., what are its benefits and limitations? How does accreditation relate with other alternative systems?
  
• What are some of the realistic options for an accreditation or alternative system? What are the key tradeoffs for each option?
  
• How could an accreditation or alternative system consider different levels and types of risk in research?
  
• What have other nations learned through their accreditation or alternative systems?
  
• What, in detail, would be the governance structure and operations of an accreditation or alternative system?
  
• How would the development and maintenance of standards related to different systems?

Relationships:

• How might an accreditation or alternative system relate to other aspects of the governance of research involving humans? (For example, complementarity with requirements in Québec and other processes, flexibility in addressing new developments (e.g., centralized research ethics review processes, private/regional research ethics boards, etc); relationship of standards to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans; international harmonization based on best practices).
  
• How will an accreditation or alternative system affect research organizations and the spectrum of disciplines and fields of research involving humans (e.g., within universities, hospitals, physicians’ offices, community health centres, and other research organizations)?

Business Plan, including costing:

• What would be a business plan for the accreditation or alternative system? This must include a detailed assessment of the costs and benefits at national, institutional and individual levels.

Transition:

• What are the practical considerations related to a transition to an accreditation or alternative system?
  
• Would a phase-in approach make sense?

Measuring impacts:

• What are some strategies for evaluating the accreditation or alternative system?

Tenure

• The Committee will complete its work within two years.

Meetings

• The Committee will determine the number and nature of its meetings in accordance with its work plan. Meetings are to be held in ways that facilitate attendance and reduce travel time and frequency. Meetings should have quorum, which is defined as half of Committee members plus one, in addition to the Chair.

Compensation

• All members sit as volunteers. As a member of the Sponsors’ Table, Health Canada will cover expenses associated with attending meetings. Therefore, Committee members will be compensated for travel expenses, accommodations and meal expenses in accordance with Treasury Board Guidelines.